Does the change in the immunization dosing schedule of 10-valent pneumococcal conjugate vaccine has any impact among children in the northwest of Sao Paulo, Brazil?

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The graphs illustrate the behaviour of the different lesions caused by HPV16, comparing the trend observed in the lesion with each of the experiments carried out. (A) Trend in cancer conditions. (B) Trend in pre-cancer conditions. (C) Trend in CIN1 lesions. (D) Trend in CIN2 lesions. (E) Trend in CIN3 lesions. EXP-1: trend in patients not receiving vaccine; EXP-2: trend in patients receiving therapeutic vaccine with dendritic cells (DC) = 10 μg/mL; EXP-3: trend in patients receiving therapeutic vaccine DC = 100 μg/mL; EXP-4: trend in patients receiving therapeutic vaccine DC = 1000 μg/mL; EXP-5: trend in patients receiving therapeutic vaccine DC = 10 μg/mL with IL-2 adjuvant; EXP-6: trend in patients receiving therapeutic vaccine DC = 10 μg/mL with Poly I:C adjuvant as TLR3 ligand; EXP-7: trend in patients receiving therapeutic vaccine DC = 10 μg/mL with CpG adjuvant as TLR9 ligand." ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "M.E. 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Arce-Salinas, Y.N. Esquivel-Torruco, A.A. Bejarano-Juvera, A.K. Bustamante-Flores, N. Aguilar-Martínez, J.G. Azcorra-López, B. Cabañas-Espinosa, E.M. Luna-Rivera, A. Hernández-Alarcón, J. Reyna Figueroa" "autores" => array:10 [ 0 => array:2 [ "nombre" => "C.A." "apellidos" => "Arce-Salinas" ] 1 => array:2 [ "nombre" => "Y.N." "apellidos" => "Esquivel-Torruco" ] 2 => array:2 [ "nombre" => "A.A." "apellidos" => "Bejarano-Juvera" ] 3 => array:2 [ "nombre" => "A.K." "apellidos" => "Bustamante-Flores" ] 4 => array:2 [ "nombre" => "N." "apellidos" => "Aguilar-Martínez" ] 5 => array:2 [ "nombre" => "J.G." "apellidos" => "Azcorra-López" ] 6 => array:2 [ "nombre" => "B." "apellidos" => "Cabañas-Espinosa" ] 7 => array:2 [ "nombre" => "E.M." "apellidos" => "Luna-Rivera" ] 8 => array:2 [ "nombre" => "A." "apellidos" => "Hernández-Alarcón" ] 9 => array:2 [ "nombre" => "J. Reyna" "apellidos" => "Figueroa" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2445146022000310?idApp=UINPBA00004N" "url" => "/24451460/0000002300000002/v3_202302191848/S2445146022000310/v3_202302191848/en/main.assets" ] "en" => array:19 [ "idiomaDefecto" => true "cabecera" => "Original article" "titulo" => "Does the change in the immunization dosing schedule of 10-valent pneumococcal conjugate vaccine has any impact among children in the northwest of Sao Paulo, Brazil?" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "119" "paginaFinal" => "124" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "R.P.-D.l. Ossa, R.G. Sieben, M.C. Cervi, D.A.F.d.S. Lima, R. Santos, D.C. Aragon" "autores" => array:6 [ 0 => array:4 [ "nombre" => "R.P.-D.l." "apellidos" => "Ossa" "email" => array:1 [ 0 => "rolapater@usp.br" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "R.G." "apellidos" => "Sieben" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "M.C." "apellidos" => "Cervi" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "D.A.F.d.S." "apellidos" => "Lima" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "b" "identificador" => "aff0010" ] ] ] 4 => array:3 [ "nombre" => "R." "apellidos" => "Santos" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] 5 => array:3 [ "nombre" => "D.C." "apellidos" => "Aragon" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "a" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Pediatric Department, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Sao Paulo, Brazil" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Microbiology Laboratory, Faculty of Medicine of Ribeirao Preto, University of Sao Paulo, Ribeirao Preto, Sao Paulo, Brazil" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "¿El cambio de las dosis en el calendario de inmunización de la vacuna conjugada antineumocócica 10-valente tiene algún impacto entre los niños del noroeste de São Paulo, Brasil?" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 3468 "Ancho" => 2508 "Tamanyo" => 332873 ] ] "descripcion" => array:1 [ "en" => "Flowchart of the inclusion process in the study, and classification of the infection episodes according to immunization schedule doses-based and diagnosis." ] ] ] "textoCompleto" => "IntroductionStreptococcus pneumoniae (S. pneumoniae) is responsible for non-invasive and invasive pneumococcal disease (IPD) principally in children under 5 years old.In Brazil, the introduction of pneumococcal conjugate vaccine, in the National Immunization Program (PNI), happened through the 10-valent pneumococcal nontypeable Haemophilus Influenzae protein conjugate vaccine (PCV-10) manufactured by GlaxoSmithKline in 2010. In January 2016 the immunization schedule was changed from 3+1 to 2+1. The IPD rate in the post-PCV-10 period in children under 18 year of age was 5.5/100,000/year.<a class="elsevierStyleCrossRef" href="#bib0080">1</a> The World Health Organization estimated the national immunization coverage in Brazil over 80% of the PCV-10.<a class="elsevierStyleCrossRef" href="#bib0085">2</a>After the first decade of introduction of the PCV-10 in Brazil, the analysis between two immunization schedules and occurrence of IPD became relevant.MethodsDesignA retrospective cohort study evaluating incidence, general characteristics and in-hospital clinical outcomes for pneumococcal infections.SettingThe study was performed in a public-affiliated tertiary-care facility. It offers acute care for a direct population of 600,000 inhabitants and a reference of 1.4 million inhabitants, admitting only patients referred by primary and secondary-care services or by ambulances. All patients under 18 years old admitted to the study facility from January 1, 2010 to December 31, 2019 were considered potentially eligible to be included in the study if they had a microbiologically confirmed IPD. We analyzed only community-associated infections. Patients could be included more than once if they had two episodes of infection at least one month apart. Were excluded episodes of colonization or asymptomatic infection.Data collectionOur departure was the microbiological laboratory data bank. We searched the genus/species identification and corresponding susceptibility test, both performed automatically by the Vitek 2 system, and confirmed by referential laboratory, Adolfo Luzt by PCR for serotype identification and susceptibility test by E-test. Demographic and clinical data were collected from the patient's medical records previously approved by the human research ethics committee(n° CAAE 20076819.2.0000.5440). All isolates were divided in two groups, the first group was defined in the period with the PCV-10 immunization schedule 3+1 corresponding to the years 2010-2015 and the second in the period with the schedule 2+1 corresponding to the years 2016–2019 according to the immunization change in the Brazilian's national immunization program.Data analysisFirst we analyzed the temporal global incidence of infections related to each one of the two immunization schedules of PCV-10 over the study period. Finally, we compared all the patients included regarding clinical presentation and in-hospital outcome. Sepsis was considered by pediatric adjusted SOFA score and septic shock by use of vasoconstrictor agents. The global mortality rate was considered for patients that died in the 30 days prior to diagnosis.Statistical analysisFor calculating the incidence risk ratio (IRR) by group we used R program 3.6.1. To associate immunization schedule with strategic outcomes of interest, simple and multiple log-binomial regression models were fitted, resulting in raw and adjusted risk estimates, considering age, vaccination history, sensitivity to penicillin and ceftriaxone as covariates. We used the statistical software SAS 9.4.ResultsFrom the initially screened 211 cultures, 135 were excluded for age>18 years and 14 were excluded because of duplication or due to patients not meeting clinical criteria for infection, 2 patients were included twice. The mean age of patients was 13.15 months, for group 3+1 was 11.08 months and for group 2+1 was 18.86 months, 58% of patients were male and 67% had a completed schedule for PCV-10. Therefore, 62 infection episodes were included in the study. 3+1 accounted for 61.3%(38/62) of the immunization schedule in 3+1 period, and 38.7%(24/62) of the immunization schedule in 2+1 period, respectively. The most common diagnosis was pneumonia in both periods and meningitis was more common in the 3+1 period than in the 2+1 period as shown in <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>.<elsevierMultimedia ident="fig0005"></elsevierMultimedia><a class="elsevierStyleCrossRef" href="#fig0010">Fig. 2</a> exhibits the incidence density rate per 1000 patients admissions in the facility during the study period divided by age. The incidence density rose in 2011 after PCV-10 introduction and again in 2018 after the schedule change, however, remains equal in both periods used IRR by person-year with a p value 0.89 (95% CI: 0.58–1.61).<elsevierMultimedia ident="fig0010"></elsevierMultimedia>In the results, 14 pneumococcal serotypes were isolated in 50 samples of positive cultures (80,6%), with 19A being the most frequent (25.8%), followed by serotype 3(11.3%), 6A(8.1%) and 6C(8.1%). In 12(19.4%) of the 62 positive samples, serotype was not identified for technical reasons. In the 2+1 group the serotype 19A had the highest absolute value(ten samples) and percentage (41.6%) in relation to all other serotypes when compared with the 3+1 group, six samples (15.8%).We observe that six (7.1%) of the samples showed resistance to penicillin and seven (11.3%) intermediate resistance. For ceftriaxone, we found four (6.4%) isolated with intermediate resistance and no sample with full resistance. For levofloxacin/ciprofloxacin and vancomycin there was no resistance. The highest percentage of resistance (52.7%) resulted for the antibiotic sulfamethoxazole/trimethoprim. Moreover, we saw a slight decrease in the penicillin resistance from 2+1 group, 2 samples (3.2%) compared to 3+1 group, 4 samples (6.4%).The outcomes tested were sepsis with RRa (adjusted relative risk) (CI 95%)=2.77 (0.28;27.42), septic shock RRa (CI 95%)=0.34 (0.10;1.11), chest drain open or closed RRa (CI 95%)=1.08 (0.43;2.66), complicated pneumonia, RRa (CI 95%)=1.05 (0.10;11.29), dead, RRa (CI 95%)=1.05 (0.10;11.29), without difference in both schedule.Besides that, we tested other outcomes such as antibiotic (days), chest drain (days), length of stay in the Intensive Care Unit (ICU) (days), length of stay (days) and mechanical ventilation (days). Regarding the survival curves, the only that showed a difference was the length of stay in the ICU, the raw hazard ratio was 2.46 CI 95% (0.93;6.48) and the adjusted was 2.52, CI 95% (0.82;7.81) like we highlighted in <a class="elsevierStyleCrossRef" href="#fig0015">Fig. 3</a>.<elsevierMultimedia ident="fig0015"></elsevierMultimedia>The global mortality rate was 8%, 3 patients had meningitis, 1 had pneumonia and 1 had occult bacteremia, 4 of them didn’t have any comorbidity.DiscussionAfter the introduction of PCV-10 in Brazil, several authors have conducted studies with the purpose of evaluating its impact on morbidity, using the hospitalization rate for pneumonia, and on mortality from IPD in children, with a significant decrease after the introduction of the vaccine.<a class="elsevierStyleCrossRefs" href="#bib0080">1,3–5</a> Regarding the incidence rates, despite an increase in the number of IPD cases in 2011 and 2018 in this analysis, we did not find any difference in both periods analyzed as observed in literature.<a class="elsevierStyleCrossRef" href="#bib0105">6</a> However, it is not possible to state that the referred result is a trend, due to continuing the evaluation of the historical series studied.Our results demonstrate a change in serotype profile, with low percentage values of serotypes included in PCV-10. There was a predominance of serotype 19A, found in PCV-13. In a prior analysis in this hospital it was observed that the most common serotype in children under 5 years and the third most common serotype between 5 and 20 years was the serotype 14, included in PCV-10. The 19A was corresponding just to 5.9% of children under 5 years.<a class="elsevierStyleCrossRef" href="#bib0110">7</a> This may highlight a serotype replacement, same as in literature.<a class="elsevierStyleCrossRefs" href="#bib0100">5,8,9</a>Regarding antimicrobial profile, we found 8% of cultures studied resistant to penicillin and a slight decrease in 2+1 group. This result is conflicting when compared to other geographical regions worldwide, in which pneumococcal resistance to penicillin occurs on a larger scale.<a class="elsevierStyleCrossRef" href="#bib0125">10</a> However, other researchers have seen the same antimicrobial profile in our country.<a class="elsevierStyleCrossRefs" href="#bib0130">11–13</a>In some countries the immunogenicity and effectiveness of 3 doses in IPD has been demonstrated despite the 4 recommended doses,<a class="elsevierStyleCrossRefs" href="#bib0105">6,14,15</a> resulting in a change in recommendations to 3 doses in countries like Brazil. The outcome of sepsis, septic shock, chest drain open or closed, complicated pneumonia and death, did not show any difference in the two immunization schedules. When other variables were analyzed, the only that showed a difference was the length of stay in the ICU. These differences may be due to improving assistance care outside and inside the hospital. However, other research shows the same effectiveness for different schedules<a class="elsevierStyleCrossRef" href="#bib0105">6</a> in IPD, the previous study did not analyze the clinical outcomes.The present study has some limitations like the lack of originality, the limitations of the study (small sample, short-follow up time, possible inconsistencies in the collected information due to the retrospective nature of the study) and the obtained results, which are inconclusive. Furthermore, It is important to carry out more complete studies to get more robust conclusions on this topic.In conclusion, two immunization schedules of PCV-10 show an equal performance in our service. Our results may highlight a serotype replacement without worse outcomes.Authors’ contributionAll authors have participated in (a) conception and design, or analysis and interpretation of the data; (b) drafting the article or revising it critically for important intellectual content; and (c) approval of the final version.FundingThe authors have no affiliation with any organization with a direct or indirect financial interest in the subject matter discussed in the manuscript.Conflict of interestsThe authors declare that they have no conflict of interest." "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres1851287" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1609732" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1851288" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1609733" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 5 => array:3 [ "identificador" => "sec0010" "titulo" => "Methods" "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0015" "titulo" => "Design" ] 1 => array:2 [ "identificador" => "sec0020" "titulo" => "Setting" ] 2 => array:2 [ "identificador" => "sec0025" "titulo" => "Data collection" ] 3 => array:2 [ "identificador" => "sec0030" "titulo" => "Data analysis" ] 4 => array:2 [ "identificador" => "sec0035" "titulo" => "Statistical analysis" ] ] ] 6 => array:2 [ "identificador" => "sec0040" "titulo" => "Results" ] 7 => array:2 [ "identificador" => "sec0045" "titulo" => "Discussion" ] 8 => array:2 [ "identificador" => "sec0050" "titulo" => "Authors’ contribution" ] 9 => array:2 [ "identificador" => "sec0055" "titulo" => "Funding" ] 10 => array:2 [ "identificador" => "sec0060" "titulo" => "Conflict of interests" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2021-01-23" "fechaAceptado" => "2021-09-11" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1609732" "palabras" => array:4 [ 0 => "Invasive pneumococcal infections" 1 => "10-Valent pneumococcal conjugate vaccine" 2 => "Brazilian children" 3 => "National immunization schedule" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1609733" "palabras" => array:4 [ 0 => "Infecciones neumocócicas invasivas" 1 => "Vacuna conjugada antineumocócica 10-valente" 2 => "Niños brasileños" 3 => "Calendario nacional de inmunización" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "Background10-Valent pneumococcal conjugate vaccine (PCV-10) is the immunization routine in Brazil since 2010. In 2016, the immunization schedules changed from 3+1 to 2+1 doses for children in the first year of age. The analysis of the relationship with the occurrence of invasive pneumococcal disease (IPD) in the different schedule vaccine period becomes relevant. MethodsThis was a retrospective cohort study evaluating the incidence, general characteristics and in-hospital clinical outcomes for invasive pneumococcal infections. We included community-associated infections by microbiological laboratory tests from 2010 to 2019. According to the immunization schedule, we divided the groups in 3+1 and 2+1. We collected clinical data from medical records. ResultsWe identified 62 cases of pneumococcal infections (3+1=38, 2+1=24). Overall, the incidence density in the two immunization schedules remains equal. The most common serotype was 19A. The outcomes of sepsis, septic shock, chest drain open or closed, complicated pneumonia and death, did not show any difference in the two schedules. Regarding the survival curves, the only one that would apply a proportional risk model (the curves do not intersect), is related to the length of stay in the ICU. In this case, the raw hazard ratio was 2.46 95% CI (0.93; 6.48) and the adjusted was 2.52, 95% CI (0.82; 7.81). ConclusionsThe two immunization schedules of PVC-10 show an equal performance in our service. Our results may highlight a serotype replacement with no worse outcomes." "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Background" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "IntroducciónLa vacuna conjugada antineumocócica 10-valente (PCV-10) es la rutina de inmunización en Brasil desde 2010. En 2016, el calendario de vacunación cambió de dosis de 3+1 para 2+1 en niños en el primer año de edad. Es de importante relevancia el análisis de la relación de la enfermedad neumocócica invasiva en los diferentes esquemas de vacunación. MétodosEste fue un estudio de cohorte retrospectivo que evaluó la incidencia, las características generales y los resultados clínicos hospitalarios de las infecciones neumocócicas invasivas. Incluimos infecciones asociadas a la comunidad mediante pruebas de laboratorio microbiológicas del 2010 al 2019. De acuerdo con el calendario de vacunación, dividimos los grupos en 3+1 y 2+1. Recolectamos datos clínicos de historias clínicas. ResultadosIdentificamos 62 casos de infecciones neumocócicas (3+1=38, 2+1=24). En general, la densidad de incidencia en los 2 calendarios de vacunación continuó siendo la misma. El serotipo más común fue el 19A. Los resultados de sepsis, shock séptico, drenaje torácico abierto o cerrado, neumonía complicada y muerte no mostraron ninguna diferencia en los 2 calendarios. En cuanto a las curvas de supervivencia, la única que aplicaría un modelo de riesgo proporcional (las curvas no se cruzan) está relacionada con el tiempo de estancia en la UCI. En este caso, la razón de riesgo bruta fue 2,46 (IC del 95%, 0,93; 6,48) y el ajustado fue 2,52 (IC del 95%, 0,82;7,81). ConclusionesLos 2 esquemas de vacunación de PVC-10 muestran un desempeño igual en nuestro servicio. Nuestros resultados pueden destacar un reemplazo de serotipos sin resultados desfavorables." 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